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| Name | Class |
|---|---|
| Universitat Autonoma de Barcelona | OTHER |
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The present project will evaluate through a Randomized Controlled Trial (RCT) with 5-month follow-up, the efficacy (5-month time horizon), adjunctive to TAU, of three 8-week interventions: a) the Mindfulness for Health program (i. e., M4H), b) a Cognitive Training (CT) program through NeuronUp platform and a program combining both (Mindfulness and Cognitive Training program, i. e., UP4H), a, as compared to TAU, in children (7-12 years old) with ADHD. In order to evaluate stability of clinical changes and to determine the mechanisms of action of the interventions studied, pre-post changes and at 5-months followup after the start of treatment will be evaluated in ADHD symptoms (inattention, hyperactivity, impulsivity), general functioning, clinical global impression, executive functions (verbal fluency, working memory, cognitive flexibility, inhibition), and comorbid symptoms (disruptive behavior, anxiety and depression) along with mindfulness skills. In the field of personalized treatment in ADHD, the design of the present study will also make it possible to establish whether certain baseline psychosocial and clinical characteristics may be associated with short- and medium-term clinical response to each of the treatments studied.
Introduction: The NeuroMind study is aimed at assessing the efficacy of 3 interventions based on Mindfulness and/or Cognitive Training programs: a Mindfulness and Cognitive Training program (i. e., UP4H), a Mindfulness program (i. e., M4H) and a Cognitive Training program (i. e. CT). This study will evaluate the short- and mid-time efficacy of these 3 interventions for the first time in children with ADHD. The objectives of this 5-month RCT, are (i) to examine the efficacy of adding UP4H, M4H or CT to treatment-as-usual (TAU) for children (7-12 years old) with ADHD; (ii) to identify pre-post differences in ADHD symptoms (inattention, hyperactivity, impulsivity), in executive functions (verbal fluency, working memory, cognitive flexibility, inhibition), and in comorbid symptoms (disruptive behavior, anxiety and depression) in the four study arms and (iii) to analyze the role of the mindful attention awareness as a psychological process variable mediator of 5-month clinical outcomes. Methods and analysis: Participants will be 120 children with ADHD (7-12 years old) recruited at CSMIJ Sant Joan de Déu Terres de Lleida (Lleida, Spain), randomly allocated to one of the four study arms: TAU vs TAU+CT vs TAU+M4H vs TAU+UP4H. A comprehensive assessment to collect ADHD symptoms (inattention, hyperactivity, impulsivity), executive functions (verbal fluency, working memory, cognitive flexibility, inhibition), comorbid symptoms (disruptive behavior, anxiety and depression), mindful attention awareness, general functioning and clinical global impression will be conducted pre-intervention, post-intervention (8 weeks), and at 5-month follow-up. Linear mixed-effects model analyses, mediation analysis and sensitivity analyses will be conducted on the basis of intention-to-treat approach and according to whether the patients are completers, or whether they completed the majority of the sessions (75% attendance).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAU + UP4H | Experimental | UP4H is a face-to-face and virtual non-pharmacological program based on Mindfulness Training and Cognitive Training. |
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| TAU + M4H | Active Comparator | M4H is a face-to-face non-pharmacological program based on Mindfulness Training. |
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| TAU + CT | Active Comparator | CT is a virtual non-pharmacological program based on Cognitive Training. |
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| Treatment as Usual (TAU) | Active Comparator | Treatment as Usual (TAU) consisted of the prescribed drugs adapted to the ADHD symptomatic profile of each child. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAU + UP4H | Behavioral | Group treatment protocol of 8 weeks (approximately 105 minutes per week, 75 of face-to-face and 30 of virtual intervention). |
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| Measure | Description | Time Frame |
|---|---|---|
| ADHD symptoms (inattention, hyperactivity, impulsivity) | Conners' Parent Rating Scale-Revised (CPRS-R) Short form | Change from baseline values at 5 months |
| ADHD symptoms (inattention, hyperactivity, impulsivity) | Conners Continuous Performance Test 3rd Edition (CPT-3) | Change from baseline values at 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Executive functions (verbal fluency, working memory, cognitive flexibility, inhibition) | Neuropsychological Assessment of Executive Functions in Children (ENFEN) | Change from baseline values at 5 months |
| Disruptive behavior, anxiety and depression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna Huguet, PhD | CSMIJ Sant Joan de Déu Terres de Lleida | Principal Investigator |
| Albert Feliu, PhD | Universitat Autonoma de Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundació Privada per a la Recerca i la Docència Sant Joan de Déu (FSJD) | Esplugues de Llobregat | Barcelona | 08950 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38384348 | Derived | Badia-Aguaron T, Royuela-Colomer E, Pera-Guardiola V, Verges-Balasch P, Cebolla A, Luciano JV, Soler J, Feliu-Soler A, Huguet Miguel A. Combining mindfulness and cognitive training in children with attention deficit hyperactivity disorder: study protocol of a pilot randomized controlled trial (the NeuroMind study). Front Psychol. 2024 Feb 7;15:1291198. doi: 10.3389/fpsyg.2024.1291198. eCollection 2024. |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| TAU + M4H | Behavioral | Group treatment protocol of 8 weekly 75 minute sessions (face-to-face intervention). |
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| TAU + CT | Behavioral | Group treatment protocol of 8 weekly 60 minutes sessions (virtual intervention). |
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| Treatment as Usual (TAU) | Other | Standard pharmacological treatment usually provided to children with ADHD. |
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Child Behavior Checklist (CBCL)
| Change from baseline values at 5 months |
| Mindful attention awareness | Mindful Attention Awareness Scale Adapted for Children (MAAS-C). Total scores of the MAAS-C range from 15 to 90, where higher scores mean a better mindful attention awareness. | Change from baseline values at 5 months |
| General functioning | Children's Global Assessment Scale (CGAS). Total scores of the CGAS range from 1 to 100, where higher scores means a better general functioning. | Change from baseline values at 5 months |
| Clinical Global Impression | Clinical Global Impression Scale (CGI). Total scores of the CGI range from 0 to 7, where higher scores means a worse clinical global impression. | Change from baseline values at 5 months |
| Anxiety | Screen for Child Anxiety Related Disorders (SCARED) | Change from baseline values at 5 months |